Galderma Announces Top-line Results from Phase 2 Clinical Dose-Escalating Study with Azzalure® / Dysport® (abobotulinumtoxinA)
Fort Worth, Texas – November 17, 2020 – Galderma today announced top-line results from a Phase 2 study on the impact of dose escalation on the duration of effect and the efficacy and safety of a single dose of Dysport®* (abobotulinumtoxinA) for Injection (50U, 75U, 100U or 125U) versus placebo for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines). Results showed that the study met its primary endpoint, with significantly more subjects treated with Dysport at all four doses achieving a composite two grade improvement responder rate than those treated with placebo at one month. Data from secondary endpoints demonstrated promising results for a potential prolonged duration of effect correlated with higher doses. Dysport**, also marketed as Azzalure® in some countries, is a prescription injection for temporary improvement in the look of moderate to severe glabellar lines in adults less than 65 years of age.
“We are encouraged that these study results demonstrate that a single dose of Dysport has a rapid onset, long-lasting effect and is well tolerated,” said John H. Joseph, M.D., investigator for the study and director of The Clinical Testing Center of Beverly Hills. “At all doses tested in the trial, Dysport had a strong safety profile, including very few cases of eyelid ptosis.”
Phase 2 Dose-Escalating Study Design and Results
The multicenter, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 study enrolled 401 subjects ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Study participants were randomized 4:1 to receive a single dose of Dysport (50U, the dose in the FDA-approved label, 75U, 100U or 125U) or placebo and followed for nine months. The primary objective of the study was to evaluate the efficacy of a single dose of Dysport as assessed by the composite responder rate at maximum frown at one month. Secondary objectives evaluated other measures of efficacy as well as duration of treatment response, subject satisfaction, aesthetic improvement and onset of treatment response.
Top-line efficacy results showed that the study met its primary endpoint. After one month, all dose groups treated with Dysport showed a statistically significant composite (investigator and subject-assessed) ≥2-grade improvement when compared with placebo. Favorable results were achieved for all doses in the secondary objectives, including a ≥1-grade improvement and subject satisfaction throughout the study duration. Dysport was well tolerated with a similar safety profile across all doses tested. Treatment-related adverse events were mild or moderate in severity and transient, and no treatment-related serious adverse events were reported.
“This phase 2 study underscores our commitment to bring efficacious products and long-lasting results to customers,” said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “Based on these encouraging safety and long-term efficacy results, as well as continued patient satisfaction, we are evaluating future clinical studies.”
*Please see full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the end of this press release.
About Galderma's collaboration with Ipsen
Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport is also marketed as Azzalure® in the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.
Dysport is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen's botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina, and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com/us.
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Dysport®(abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
**Dysport is also marketed as Azzalure® in EU for the treatment of glabellar lines with more than 40 million treatments in the EU and US combined and approval in 72 countries.
Important Safety Information
What is the most important information you should know about Dysport? Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre‐existing before injection.
These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow’s milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.
The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.
Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert‐Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing. Serious allergic reactions have occurred with the use of Dysport. Dry eye has also been reported.
Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can’t be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any in the past (be sure your doctor knows exactly which product you received, have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.
Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.
Ask your doctor if Dysport is right for you.
You are encouraged to report negative side effects of prescription drugs to the FDA or your relevant local regulator.
Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
The Dysport trademark is used under license. All trademarks are the property of their respective owners.